Using digital devices to monitor respiratory virus infections

Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies

This study is testing whether wearable devices like smartwatches can help track health changes in people with respiratory virus infections to better understand how severe the illness might be.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT04772170 on ClinicalTrials.gov

What this trial studies

This observational study aims to utilize wearable and sensor devices, such as smartwatches and smartphones, to collect health data from participants enrolled in respiratory virus challenge studies. Participants will wear these devices continuously during their stay at the NIH Clinical Center and during follow-up visits to monitor various health metrics, including cough frequency, heart rate, and temperature. The goal is to identify digital biomarkers that correlate with respiratory virus infections and develop predictive models for influenza disease severity. By analyzing the data collected, researchers hope to uncover subtle health changes that may indicate infection.

Who should consider this trial

Good fit: Ideal candidates are healthy adults currently enrolled or scheduled to enroll in a respiratory virus challenge study at the NIH.

Not a fit: Patients with conditions that may interfere with the ability to wear monitoring devices or provide informed consent may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved monitoring and early detection of respiratory virus infections, enhancing patient care.

How similar studies have performed: While the use of digital devices in monitoring health is gaining traction, this specific approach to correlate digital biomarkers with respiratory virus infections is relatively novel.

Eligibility criteria

* INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Able to provide informed consent.
2. Current, recent, or planned enrollment in a respiratory virus challenge study at the NIH Clinical Center.
3. Willing to wear devices as instructed.
4. Willing to participate in monitoring activities as instructed.
5. Willing to have monitoring data stored.
6. Willing to have monitoring data shared with protocol investigators at NIH, University of Washington, and University of Toronto.
7. Willing to have select clinical data from the challenge study such as vital signs, viral shedding, pulmonary function test and/or spirometry results, and clinical symptoms data shared with investigators at University of Washington and University of Toronto.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

1\. Any condition that, in the opinion of the investigator, contraindicates participation in this study.

Co-enrollment guidelines: Participants must be co-enrolled, planned for co-enrollment, or recently enrolled in a challenge study. Co-enrollment in other studies is restricted but may take place after study staff notification and only with approval of the principal investigator or designee.

Where this trial is running

Bethesda, Maryland

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Luca T Giurgea, M.D. — National Institute of Allergy and Infectious Diseases (NIAID)
• Study coordinator: Rani S Athota, Ph.D.

Conditions Influenza; Respiratory Virus; Coronavirus; Wearable Digital Device; Bed Sensor; Smartphone; Cough Count; Smartwatch